SULFAMETHOXAZOLE AND TRIMETHOPRIM injection, solution, concentrate

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

SULFAMETHOXAZOLE (UNII: JE42381TNV) (SULFAMETHOXAZOLE - UNII:JE42381TNV), TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)

Saadav alates:

Teva Parenteral Medicines, Inc.

INN (Rahvusvaheline Nimetus):

SULFAMETHOXAZOLE

Koostis:

SULFAMETHOXAZOLE 80 mg in 1 mL

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Sulfamethoxazole and Trimethoprim Injection is indicated in the treatment of Pneumocystis jirovecii pneumonia in adults and pediatric patients two months of age and older. Sulfamethoxazole and Trimethoprim Injection is indicated in the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei in adults and pediatric patients two months of age and older. Sulfamethoxazole and Trimethoprim Injection is indicated in the treatment of severe or complicated urinary tract infections in adults and pediatric patients two months of age and older due to susceptible strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris when oral administration of Sulfamethoxazole and Trimethoprim Injection is not feasible and when the organism is not susceptible to single-agent antibacterials effective in the urinary tract. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sulfamethoxa

Toote kokkuvõte:

Sulfamethoxazole and Trimethoprim Injection USP is supplied as follows: NDC Numbers Sulfamethoxazole, USP Strength Trimethoprim, USP Strength Pack Size 0703-9503-03 400 mg/5 mL (80 mg/mL) 80 mg/5 mL (16 mg/mL) 5 mL single dose amber vials packaged 10 per carton. 0703-9514-03 10 mL multiple dose amber vials packaged 10 per carton. 0703-9526-01 2400 mg/30 mL (80 mg/mL) 480 mg/30 mL (16 mg/mL) 30 mL multiple dose amber vials packaged individually. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DO NOT REFRIGERATE.  

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND
TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE
TEVA PARENTERAL MEDICINES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SULFAMETHOXAZOLE
AND TRIMETHOPRIM INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION.
SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
Sulfamethoxazole and Trimethoprim Injection is a combination of
sulfamethoxazole, a sulfonamide
antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor
antibacterial, indicated in adults and
pediatric patients two months of age and older for treatment of
infections caused by designated,
susceptible bacteria.
_Pneumocystis jirovecii _Pneumonia (1.1)
Shigellosis (1.2)
Urinary Tract Infections (1.3)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Sulfamethoxazole
and Trimethoprim Injection and other antibacterial drugs,
Sulfamethoxazole and Trimethoprim Injection
should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by
susceptible bacteria. (1.4)
DOSAGE AND ADMINISTRATION
DOSAGE GUIDELINES FOR ADULTS AND PEDIATRIC PATIENTS (TWO MONTHS OF AGE
AND OLDER)
INFECTION
TOTAL DAILY DOSE (BASED ON
TRIMETHOPRIM CONTENT)
FREQUENCY
DURATION
_Pneumocystis _
_ jirovecii _Pneumonia
15 to 20 mg/kg (in 3 or 4 equally divided doses)
Every 6 to 8 hours
14 days
Severe Urinary
Tract Infections
8 to 10 mg/kg (in 2 to 4 equally divided doses) Every 6, 8 or 12 hours
14 days
Shigellosis
8 to 10 mg/kg (in 2 to 4 equally divided doses) Every 6, 8 or 12 hours
5 days
For patients with impaired renal function, a reduced dosage should be
employed. (2.2)
Sulfamethoxazole and Trimethoprim Injection must be given by
intravenous infusion over a period of 60
to 90 minutes. Rapid infusion or bolus injection must be avoided.
(2.3)
Sulfamethoxazole and